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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA ANESTHESIA SET COAX GSL 230; BREATHING HOSE, DISPOSABLE
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DRÄGERWERK AG & CO. KGAA ANESTHESIA SET COAX GSL 230; BREATHING HOSE, DISPOSABLE Back to Search Results
Catalog Number MP00358
Device Problems Obstruction of Flow (2423); Detachment of Device or Device Component (2907)
Patient Problems Bradycardia (1751); Unspecified Respiratory Problem (4464)
Event Date 01/19/2023
Event Type  Injury  
Event Description
It was reported that the inner lumen of the coax breathing circuit is loose and can be twisted inside the outer lumen.The inner lumen got twisted up to a point where the patient received almost no air through the inspiratory lumen resulting in a life-threatening injury.
 
Manufacturer Narrative
The investigation is still on-going.The results will be provided with a follow-up report.
 
Manufacturer Narrative
The affected hose system of type anesthesia set coax was available for investigation.During the analysis at manufacturing site the described problem of a loose inner circuit could not be confirmed.It was found that the outer circuit was loose so that the rotation of the patient connection resulted in a twisting of the inner circuit.As a result of a twisted inner circuit a blockage can occur leading to an increased airway pressure.This is detected by the connected main device and depending on the set alarm limits a corresponding alarm will be posted.Our investigations have shown that the adhesive joint did not conform to specification due to an unstable manufacturing process.A capa was opened to initiate and document further measures.In april 2023, dräger has already informed all customers of potentially affected products about the identified risk with a field safety notice.
 
Event Description
It was reported that the inner lumen of the coax breathing circuit is loose and can be twisted inside the outer lumen.The inner lumen got twisted up to a point where the patient received almost no air through the inspiratory lumen resulting in a life-threatening injury.
 
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Brand Name
ANESTHESIA SET COAX GSL 230
Type of Device
BREATHING HOSE, DISPOSABLE
Manufacturer (Section D)
DRÄGERWERK AG & CO. KGAA
moislinger allee 53-55
lübeck
GM 
Manufacturer (Section G)
DRÄGERWERK AG & CO. KGAA
moislinger allee 53-55
lübeck 23542
GM   23542
Manufacturer Contact
moislinger allee 53-55
lübeck 23542
4518822868
MDR Report Key16332679
MDR Text Key309129755
Report Number9611500-2023-00052
Device Sequence Number1
Product Code CAI
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/22/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/09/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberMP00358
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/24/2023
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Life Threatening;
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